humanFeed & Digestive Products

Levocetirizine Dihydrochloride

Composition

Acitrin-L Tablet: Each film coated tablet contains Levocetirizine Dihydrochloride INN 5 mg.

Acitrin-L Oral solution: Each 5 ml contains Levocetirizine Dihydrochloride INN 2.5 mg.

Description

Acitrin-L ® is a preparation of Levocetirizine Dihydrochloride. Levocetirizine is the active (Levo) isomer of Cetirizine. It has an affinity for the human H 1 -receptor 2-fold higher than that of Cetirizine. It is a new highly effective and well tolerated non-sedating antihistamine with potent antiallergic properties.

Indications

Relief of symptoms associated with seasonal allergic rhinitis in adults and children

Relief of symptoms associated with perennial allergic rhinitis in adults and children

Treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children

Dosage & Administration

Route: Oral

Adults and children >6 years:

One Acitrin-L ® tablet (5 mg) once daily.

Oral solution:

Adults & children >12 years: 10 mL (2 teaspoonfuls) once daily.

Children 6–11 years: 5 mL (1 teaspoonful) once daily.

Children 6 months–5 years: 2.5 mL (1/2 teaspoonful) once daily.

Children <6 months: Not recommended.

Renal & Hepatic impairment:

eGFR 30–50 mL/min/1.73 m²: 5 mg on alternate days.

eGFR 10–30 mL/min/1.73 m²: 5 mg every 3 days.

eGFR <10 mL/min/1.73 m²: Avoid / Contraindicated.

Hepatic impairment: No adjustment needed if renal function intact. Both impairments: dose adjustment recommended.

Interaction

Alcohol and central nervous system depressants enhance somnolence and cognitive impairment; theophylline decreases levocetirizine clearance; ritonavir increases systemic exposure.

Contraindications

The use of Levocetirizine is contraindicated in patients with known hypersensitivity to Levocetirizine or any of its ingredients, or to Cetirizine. Observed reactions range from urticaria to anaphylaxis. It is also contraindicated in patients with end-stage renal disease (CL CR < 10 mL/min) and patients undergoing hemodialysis and children with impaired renal function.

Side Effects

Less Common: Headache, dry mouth, fatigue. Rare: Skin rash.

Overdose

Symptoms of overdose may include drowsiness in adults and initially agitation and restlessness, followed by drowsiness in children. There is no known specific antidote to Levocetirizine. In case of overdose occurrence, symptomatic or supportive treatment is recommended. Levocetirizine is not effectively removed by dialysis, and dialysis will be ineffective unless a dialyzable agent has been concomitantly ingested.

Pregnancy & Lactation

Category B. Safety in pregnancy has not been established; use only if potential maternal benefits clearly outweigh fetal risks. Lactation: Levocetirizine passes into breast milk; discontinue nursing or discontinue drug.

Precautions & Warnings

Caution patients against engaging in hazardous occupations requiring complete mental alertness and motor coordination, such as operating machinery or driving a motor vehicle.

Avoid concurrent use of Levocetirizine with alcohol or other central nervous system depressants due to potential additive impairment of CNS performance.